Federal Advisory Panel Urges Limits and Warnings for Antibiotic Ketek
December 18, 2006--At the conclusion of Friday’s review of Ketek’s safety at
a joint meeting of the FDAs Drug Safety and Risk Management Advisory Committee
and the Anti-infective Drug Advisory Committee, the panel members urged that
Ketek be limited in the way it is prescribed and requested that stronger
warnings be made on its labeling information.
Though the panel stopped
short of removing Ketek from the market, it voted to restrict its
use.
The experts voted 17 to 2 against the continued use of Ketek in the
treatment of more minor conditions such as bacterial exacerbations of sinusitis
and bronchitis. They felt the risks outweighed the benefits in this patient
population, citing data showing that these conditions often resolve on their own
without treatment.
Additionally, the panel voted 16 to 3 to continue to
allow Ketek’s use in the treatment of mild to moderate community acquired
pneumonia--but only as second line treatment.
The panel members also
recommended the inclusion of a black box warning for the increased risk of liver
failure, exacerbations of myasthenia gravis, visual disturbances and loss of
consciousness.
see also:
Approval Worries
Find out what the FDA's latest approval worries are about KetekThere are new worries about the approval of the dangerous drug Ketek
FDA News Release
The FDA's latest warning about the dangers of KetekThe Danger behind Ketek - A new FDA warning
From the FDA
Concerned with Ketek safety? Hear what the FDA warnsFor your health: What the FDA thinks about the harmful drug Ketek
